AtherosclerosisNCT00063440
Epidemiology of Carotid IMT Progression in MESA - Ancillary Study
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Tufts Medical Center.
Trial summary
To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis. Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- How many people
- 5,610 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of the Multi-Ethnic Study of Atherosclerosis, a cross-sectional NIH population cohort originating from 6 regions in the United States
Members of MESA study
About this study
To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis.
Read the detailed description
BACKGROUND:
Cardiovascular disease remains the leading cause of death in the United States and one of the leading causes of morbidity. New technology recently has allowed the non-invasive investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the clinical implications and significance of this new technology have not yet been fully examined nor has the interrelationship between these various measurements of clinical and sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in several ethnic groups.
DESIGN NARRATIVE:
A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the scheduled follow-up visits in MESA subjects in order to study the relationship between carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies will be conducted on how these two non-invasive markers of atherosclerosis relate to cardiovascular disease risk factors and clinical events.The study will utilize the MESA cohort involving 6500 subjects who will have baseline and four follow-up examinations. coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC determinations also scheduled at follow-up. IMT determinations will be added in conjunction with the CAC studies in the second and third exams and detailed analyses will be carried out on these two measures of atherosclerotic burden that may reflect different biologic processes.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Arteriosclerosis
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Common carotid artery intima-media thickness
Measured: randomly selected at 2 years or 4 years in 1/2 of the cohort
Secondary outcomes (1)
Common carotid artery diameter
Measured: randomly selected at 2 or 4 years for each 1/2 of the cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2003 (estimated)
- Study startJun 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Joseph F Polak, MD, MPH, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063440
- Sponsor's protocol ID
- 1214
- Other IDs
- 5R01HL069003-05
- Status last verified
- Feb 2013
- First submitted
- 26 Jun 2003
- Last updated
- 8 Feb 2013
- Results posted
- No
Publications
Polak JF, Herrington D, O'Leary DH. Associations of edge-detected and manual-traced common carotid artery intima-media thickness with incident peripheral artery disease: The Multi-Ethnic Study of Atherosclerosis. Vasc Med. 2019 Aug;24(4):306-312. doi: 10.1177/1358863X19835925. Epub 2019 Apr 26.
PubMed 31023166Polak JF, O'Leary DH. Edge-detected common carotid artery intima-media thickness and incident coronary heart disease in the multi-ethnic study of atherosclerosis. J Am Heart Assoc. 2015 Jun 15;4(6):e001492. doi: 10.1161/JAHA.114.001492.
PubMed 26077584Polak JF, Sacco RL, Post WS, Vaidya D, Arnan MK, O'Leary DH. Incident stroke is associated with common carotid artery diameter and not common carotid artery intima-media thickness. Stroke. 2014 May;45(5):1442-6. doi: 10.1161/STROKEAHA.114.004850. Epub 2014 Mar 18.
PubMed 24643408Polak JF, Johnson C, Harrington A, Wong Q, O'Leary DH, Burke G, Yanez ND. Changes in carotid intima-media thickness during the cardiac cycle: the multi-ethnic study of atherosclerosis. J Am Heart Assoc. 2012 Aug;1(4):e001420. doi: 10.1161/JAHA.112.001420. Epub 2012 Aug 24.
PubMed 23130162Polak JF, Wong Q, Johnson WC, Bluemke DA, Harrington A, O'Leary DH, Yanez ND. Associations of cardiovascular risk factors, carotid intima-media thickness and left ventricular mass with inter-adventitial diameters of the common carotid artery: the Multi-Ethnic Study of Atherosclerosis (MESA). Atherosclerosis. 2011 Oct;218(2):344-9. doi: 10.1016/j.atherosclerosis.2011.05.033. Epub 2011 Jun 14.
PubMed 21726862
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Carotid IMT Progression in MESA - Ancillary Study
- ClinicalTrials.gov ID
- NCT00063440
- Acronym / sponsor ID
- 1214
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,610 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis.
Detailed description
BACKGROUND:
Cardiovascular disease remains the leading cause of death in the United States and one of the leading causes of morbidity. New technology recently has allowed the non-invasive investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the clinical implications and significance of this new technology have not yet been fully examined nor has the interrelationship between these various measurements of clinical and sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in several ethnic groups.
DESIGN NARRATIVE:
A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the scheduled follow-up visits in MESA subjects in order to study the relationship between carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies will be conducted on how these two non-invasive markers of atherosclerosis relate to cardiovascular disease risk factors and clinical events.The study will utilize the MESA cohort involving 6500 subjects who will have baseline and four follow-up examinations. coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC determinations also scheduled at follow-up. IMT determinations will be added in conjunction with the CAC studies in the second and third exams and detailed analyses will be carried out on these two measures of atherosclerotic burden that may reflect different biologic processes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the Multi-Ethnic Study of Atherosclerosis, a cross-sectional NIH population cohort originating from 6 regions in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Common carotid artery intima-media thickness
Time frame: randomly selected at 2 years or 4 years in 1/2 of the cohort
1 secondary outcome
Common carotid artery diameter
Time frame: randomly selected at 2 or 4 years for each 1/2 of the cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Derived from this study: PubMed 31023166Polak JF, Herrington D, O'Leary DH. Associations of edge-detected and manual-traced common carotid artery intima-media thickness with incident peripheral artery disease: The Multi-Ethnic Study of Atherosclerosis. Vasc Med. 2019 Aug;24(4):306-312. doi: 10.1177/1358863X19835925. Epub 2019 Apr 26.
- Derived from this study: PubMed 26077584Polak JF, O'Leary DH. Edge-detected common carotid artery intima-media thickness and incident coronary heart disease in the multi-ethnic study of atherosclerosis. J Am Heart Assoc. 2015 Jun 15;4(6):e001492. doi: 10.1161/JAHA.114.001492.
- Derived from this study: PubMed 24643408Polak JF, Sacco RL, Post WS, Vaidya D, Arnan MK, O'Leary DH. Incident stroke is associated with common carotid artery diameter and not common carotid artery intima-media thickness. Stroke. 2014 May;45(5):1442-6. doi: 10.1161/STROKEAHA.114.004850. Epub 2014 Mar 18.
- Derived from this study: PubMed 23130162Polak JF, Johnson C, Harrington A, Wong Q, O'Leary DH, Burke G, Yanez ND. Changes in carotid intima-media thickness during the cardiac cycle: the multi-ethnic study of atherosclerosis. J Am Heart Assoc. 2012 Aug;1(4):e001420. doi: 10.1161/JAHA.112.001420. Epub 2012 Aug 24.
- Derived from this study: PubMed 21726862Polak JF, Wong Q, Johnson WC, Bluemke DA, Harrington A, O'Leary DH, Yanez ND. Associations of cardiovascular risk factors, carotid intima-media thickness and left ventricular mass with inter-adventitial diameters of the common carotid artery: the Multi-Ethnic Study of Atherosclerosis (MESA). Atherosclerosis. 2011 Oct;218(2):344-9. doi: 10.1016/j.atherosclerosis.2011.05.033. Epub 2011 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph F Polak, MD, MPH principal investigator
Tufts Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Tufts Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common carotid artery intima-media thickness (time frame: randomly selected at 2 years or 4 years in 1/2 of the cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00063440, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.